Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation

NCT04074057 | Unknown

• 1 other identifier: 2018/00977
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

n Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016. International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016. According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly. In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training. Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues. Current solutions to increase participation and compliance involve strategies have been limited. Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs. Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required. Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation. In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use. "Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (8)

• 6 minutes walk test

  The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The MCID for 6MWD in patients with CAD after ACS was 25m.

  through study completion, an average of 1 year

• Body weight

  Body weight will be assessed , record in kg

  through study completion, an average of 1 year

• Body Height

  Body height will be assessed, record in meter

  through study completion, an average of 1 year

• Body Mass Index

  Measure of body fat based on height and weight that applies to adult men and women. Calculated by using body weight and height (kg/m2)

  through study completion, an average of 1 year

• Body Fat Percentage

  Assess using a bioelectrical impedance analysis (BIA) method, record in percentage %

  through study completion, an average of 1 year

• Skeletal muscle mass

  Assess using a bioelectrical impedance analysis (BIA) method, record in kg

  through study completion, an average of 1 year

• Waist Hip Ratio

  Assess using a bioelectrical impedance analysis (BIA) method

  through study completion, an average of 1 year

• Borg's RPE scale

  Rating of perceived exertion (RPE) is a widely used and reliable indicator to monitor and guide exercise intensity. The scale allows individuals to subjectively rate their level of exertion during exercise or exercise testing. body fat,Skeletal muscle mass, Waist-hip ratio can be measured by using the body composition analysis machine. Borg scale 6-20, 6 is very very light and 20 is very very hard.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Self-Efficacy for Exercise Scale•

  through study completion, an average of 1 year

• Health related QoL: MacNew myocardial infarction Quality of life questionnaire

  through study completion, an average of 1 year

• Patient-reported survey on usability of Heart Track acceptability

  through study completion, an average of 1 year

Study Arms (2)

Control arm

OTHER

the control group will undergo a conventional weekly CR programme lasting 8-12 sessions. Components of each session will include warm up, aerobic training, resistance exercises and cool down. Patients are encouraged to continue their home exercises, exercising another 2 times a week at home and record down using an activity diary. The importance of CR programme and exercise advice will be explained and reinforced by the CR Physiotherapist. The submaximal exercise test and a body composition analysis will be repeated on the final assessment. Every week research coordinator will call the subject to remind them to exercise.

Other: Conventional Cardiac Rehab Classes

Intervention arm

OTHER

During the initial assessment, the importance of CR and regular exercise will be explained and reinforced by CR physiotherapist. A research assistant will teach the patient how to use "Heart Track". The patient will then bring "Heart Track" home to continue their CR program. Patient will then undergo the whole CR programme to exercise for 3 times a day for 8-12 weeks using "Heart Track". Each "Heart Track" session will include warm up, aerobic training, resistance exercises and cool down (same as the traditional CR session). After 8-12 weeks, patient will be called back to the clinic by the research assistant to complete the final assessment (sub-maximal exercise test and a body composition analysis) with the blinded assessor. Every week research coordinator will call the subject to remind them to exercise.

Device: Heart Track

Interventions

Conventional Cardiac Rehab Classes OTHER

conventional weekly CR programme lasting 8-12 sessions.

Control arm

Heart Track DEVICE

Key components of "Heart-Track" are a heart rate sensor, a mobile app and a remote monitoring portal. The "Heart-Track" mobile app is synchronized/ connected to Polar heart rate sensor through bluetooth in order to provide continous heart rate monitoring when subjects are exercising. This is to ensure safety and exercise effectiveness.

Intervention arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Underwent coronary revascularisation follow AMI
• Language literacy English or Mandarin
• Owns a smart phone
• Normal physiological response during exercise testing
• Low or moderate risk following risk stratification.

You may not qualify if:

• Medically unfit for exercise
• Post op complication
• High risk following risk stratification
• Cognitive impaired

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Eng Chuan Neoh, masters

  Senior Physiotherapist

  STUDY DIRECTOR

Central Study Contacts

Eng Chuan Neoh, Masters

CONTACT

91733222; eng_chuan_neoh@ttsh.com.sg

Jaclyn Chow, Masters

CONTACT

98221880; jaclyn_jl_chow@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization and group allocation are done by the research coordinator. Final assessment is also arranged by research coordinator. Blinded assessor will conduct the final assessment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist

Model Details: All patients who are referred for Cardiac Rehabilitation post discharge from hospital will be assessed by the Physiotherapist during the first follow-up appointment to determine eligibility for inclusion. During this session, exercise testing and a body composition analysis will be done for every patient. The Physiotherapist will then stratify all patients into low, moderate and high-risk groups only those with low and moderate risk will be included into the study after informed consent is attained. A research assistant randomise the patients into two groups, namely the intervention group or the control group. Block randomisation method will be used by using the randomisation function in Red Cap created by independent aata manager who is not part of the study team.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 29, 2019
• Study Start: May 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)